| iQFlex Pro (K240009) | First Source, Inc. | 2024-07-03 |
| AOS Marker Seeds (SMG0242-025) (K233626) | Alpha-Omega Services, Inc. | 2024-07-02 |
| SMART Bun-Yo-Matic X-Ray (K240736) | Disior, Ltd. | 2024-07-02 |
| ViewPoint 6 (K241300) | Ge Healthcare GmbH | 2024-07-02 |
| cNeuro cDAT (K233908) | Combinostics OY | 2024-07-01 |
| Hyper Insight - ICH (K240353) | Sk, Inc. | 2024-07-01 |
| nordicMEDiVA (K241608) | Nordicneurolab AS | 2024-06-28 |
| Magnifico Open (100009900); Magnifico MSK ( 100009910) (K241133) | Esaote, S.p.A. | 2024-06-26 |
| SC1 Handheld Ultrasound Imaging system (Model: SC1) (K233579) | Fcu Co., Ltd. | 2024-06-26 |
| TRIDENT Mobile Fluoroscopy System (K233380) | Dornier Medtech America | 2024-06-26 |
| VEA Align; spineEOS (K240582) | Eos Imaging | 2024-06-25 |
| O-arm O2 Imaging System (K240465) | Medtronic Navigation, Inc. | 2024-06-21 |
| V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System (K240631) | Samsung Medison Co., Ltd. | 2024-06-21 |
| Medihub Prostate (K233196) | JLK, Inc. | 2024-06-21 |
| See Factor CT3™ (K233230) | Epica International, Inc. | 2024-06-21 |
| SMART Bun-Yo-Matic CT (K240642) | Disior, Ltd. | 2024-06-20 |
| MediOMx (K233331) | Pmx, Inc. | 2024-06-17 |
| Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System (K240684) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-06-17 |
| SIS System (K241083) | Surgical Information Sciences, Inc. | 2024-06-14 |
| Clarius OB AI (K233955) | Clarius Mobile Health Corp. | 2024-06-14 |
| Relu Creator (K233925) | Relu BV | 2024-06-13 |
| Radiography 7300 C (K233662) | Philips Medical Systems Dmc GmbH | 2024-06-13 |
| 21.3” 5MP Color LCD Display UMD5-21B01 (K241499) | Acula Technology Corp. | 2024-06-13 |
| ACUSON SC2000 Diagnostic Ultrasound System (K233613) | Siemens Medical Solutions USA, Inc. | 2024-06-12 |
| RS85 Diagnostic Ultrasound System (K240516) | Samsung Medison Co., Ltd. | 2024-06-12 |
| ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System (K233610) | Siemens Medical Solutions USA, Inc. | 2024-06-12 |
| Venue (K240111) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 |
| Venue Go (K240053) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 |
| Venue Sprint (K240206) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 |
| OmniTom Elite (K233767) | Neurologica Corporation | 2024-06-10 |
| Venue Fit (K234106) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 |
| iLoop Interventional Coil 0.55T (K241069) | Noras Mri Products GmbH | 2024-06-07 |
| EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) (K234042) | Ever Fortune.Ai, Co., Ltd. | 2024-06-07 |
| Cardiac CT Function Software Application (K241038) | Circle Cardiovascular Imaging | 2024-06-07 |
| BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) (K232738) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2024-05-31 |
| Bone Suppression Software (K240281) | Konica Minolta, Inc. | 2024-05-31 |
| CINA-VCF (K240612) | Avicenna.Ai | 2024-05-31 |
| Mimics Enlight CMF (K223427) | Materialise NV | 2024-05-31 |
| SET-5002 (K240827) | Shimadzu Corporation Medical Systems Division | 2024-05-24 |
| uPMR 790 (K234154) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-24 |
| LVivo IQS (K240769) | Dia Imaging Analysis, Ltd. | 2024-05-24 |
| Syngo Carbon Enterprise Access (VA40A) (K240294) | Siemens Healthcare GmbH | 2024-05-23 |
| VinDr-Mammo (K233108) | Vinbigdata Joint Stock Company | 2024-05-23 |
| Zenition 90 (K240224) | Philips Medical Systems Nederlands B.V. | 2024-05-22 |
| IntraOp Alignment System (K240199) | Alphatec Spine, Inc. | 2024-05-22 |
| Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (K232759) | Brainlab AG | 2024-05-21 |
| 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) (K233336) | Acula Technology Corp. | 2024-05-21 |
| YSIO X.pree (K233543) | Siemens Medical Solutions | 2024-05-21 |
| MIM - Centiloid Scaling (K233620) | Mim Software, Inc. | 2024-05-20 |
| Radiance V5 (K233236) | Gmv Soluciones Globales Internet S.A.U. | 2024-05-17 |
| uOmnispace.CT (K233209) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-17 |
| HD80 Series Ultrasound Diagnostic System (K233841) | Qingdao Hisense Medical Equipment Co., Ltd. | 2024-05-16 |
| BriefCase-Quantification (K241112) | Aidoc Medical , Ltd. | 2024-05-15 |
| Heuron ICH (K233247) | Heuron Co., Ltd. | 2024-05-15 |
| MIM – Monte Carlo Dosimetry (K232862) | Mim Software, Inc. | 2024-05-13 |
| Brainomix 360 e-Lung (K233875) | Brainomix Limited | 2024-05-13 |
| APERTO Lucent MRI System (K233629) | FUJIFILM Healthcare Americas Corporation | 2024-05-10 |
| SmartChest (K232410) | Milvue | 2024-05-10 |
| Flexible Fixation Device for Gynecological Applicators (GM11001960) (K240495) | Varian Medical Systems, Inc. | 2024-05-09 |
| VUZE System (K232976) | Vuze Medical , Ltd. | 2024-05-09 |
| Eve Patient Positioner System (K231612) | Leo Cancer Care | 2024-05-07 |
| DeepContour (V1.0) (K232928) | Wisdom Technologies., Inc. | 2024-05-07 |
| MIM – Dose Analysis (K232514) | Mim Software, Inc. | 2024-05-06 |
| CT 5300 (K232491) | Philips Healthcare (Suzhou) Co., Ltd. | 2024-05-03 |
| ECHELON Synergy V10.0 (K233687) | FUJIFILM Healthcare Americas Corporation | 2024-05-03 |
| B-Ultrasound Diagnostic System (K232895) | Contec Medical Systems Co.,Ltd | 2024-05-03 |
| Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) (K232908) | Contec Medical Systems Co.,Ltd | 2024-05-02 |
| Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) (K232923) | Varian Medical Systems, Inc. | 2024-04-30 |
| SubtleREFORMAT (1.x) (K233699) | Subtle Medical, Inc. | 2024-04-29 |
| FCT iSTREAM Phase 1 (K233583) | FUJIFILM Healthcare Americas Corporation | 2024-04-26 |
| uMR Jupiter (K233673) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-26 |
| Sonio Detect (K240406) | Sonio | 2024-04-26 |
| DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl (K232298) | Canon, Inc. | 2024-04-26 |
| syngo.via RT Image Suite (K232799) | Siemens Medical Solutions USA, Inc. | 2024-04-26 |
| Pocket III (K232302) | Quantel Medical | 2024-04-26 |
| Dental Cone-beam Computed Tomography (K240855) | Yian Medical Technology (Haining) Co., Ltd. | 2024-04-25 |
| InVision Precision LVEF (LVEF) (K232331) | InVision Medical Technology Corporation | 2024-04-25 |
| OpenRad Cloud (K240839) | Openrad Services Uk, Ltd. | 2024-04-24 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K240850) | Philips Ultrasound, LLC | 2024-04-24 |
| Image Management V15 (K240822) | Philips Medical Systems Technologies | 2024-04-24 |
| Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System (K240115) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-04-22 |
| Rapid (K233582) | Ischemaview, Inc. | 2024-04-22 |
| ART-Plan (v.2.2.0) (K234068) | Therapanacea Sas | 2024-04-22 |
| uOmnispace.MR (K233186) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-17 |
| VisAble.IO (K240773) | Techsomed | 2024-04-15 |
| VenusX (K232489) | Linatech, LLC | 2024-04-12 |
| Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR (K240238) | Canon Medical Systems Corporation | 2024-04-12 |
| OASIS MRI System (K240571) | Fujifilm Healthcare Corporation | 2024-04-12 |
| True Enhance DL (K233698) | Ge Healthcare Japan Corporation | 2024-04-11 |
| uMR 680 (K240744) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-10 |
| Neorad Pacs (Neorad Pacs) (K232641) | Everrtech Software Pvt, Ltd. | 2024-04-10 |
| Universal Endometrial Applicator Set (GM11009840) (K232623) | Varian Medical Systems, Inc. | 2024-04-09 |
| CAAS Workstation (K232147) | Pie Medical Imaging BV | 2024-04-09 |
| Rho (DEN230023) | 16 Bit, Inc. | 2024-04-09 |
| EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (K240291) | Ever Fortune.Ai, Co., Ltd. | 2024-04-08 |
| ABLATE-IQ (K232227) | Neuwave Medical, Inc. | 2024-04-04 |
| Preview Shoulder (K240172) | Genesis Software Innovations | 2024-04-04 |
| AI-Rad Companion Organs RT (K232899) | Siemens Medical Solutions U.S.A. | 2024-04-03 |
| ECG-less Cardiac (K233750) | Ge Medical Systems, LLC | 2024-04-02 |
| Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System (K232835) | Canon Medical Systems Corporation | 2024-04-02 |